Company Overview

This is a company that develops diagnostic tests using CRISPR-Cas13.

Title: Director/Senior Director, Regulatory Affairs — JO-2207-5801

Territory: REMOTE - U.S.

Therapeutic Area: Diagnostics/Device

The Director plays a critical role in defining, developing, and managing the Company's regulatory strategy in support of successful submissions across a portfolio of indications for both domestic and international markets. Throughout the product life cycle, the Director will be a key advisor and enabler of successful collaboration both internal and external to the organization.

Essential Duties and Responsibilities

• Develop regulatory strategies including, for example, presubmission, US and OUS, platform (and possibly device family) and assay, and approach to MDSAP and IVDD/IVDR.
• Prepare FDA submissions which may include: facility registration, device listings, 510(k)s, IDEs, FDA meeting requests and associate documentation, de novo submissions, PMAs, CLIA Waiver, etc.
• Prepare regulatory submissions including the identification, compilation, and submission of information necessary to obtain international regulatory approvals, including export certificates from FDA, and dossiers required by foreign regulatory bodies. Assist foreign licensees with registration of the Company’s products in OUS territories.
• Maintain compliance of all approved materials and work cross-functionally on any requested updates or additional studies.
• Communicate with regulatory agencies regarding the status of regulatory information requests and regulatory submissions.
• Communicate with company management regarding regulatory strategy for potential products, new regulatory requirements, trends or risks and the status of regulatory submissions and standings.
• Collaborate cross-functionally to provide guidance to development teams as well as sub-teams to coordinate regulatory strategies and tactics for product development and support.
• Maintain all regulatory files and documentation.
• Develop Company/departmental procedures, policies and trainings which assure consistent, accurate, and efficient processing of required submissions.
• Contribute to company QMS procedures to ensure tailorable conformity to regulatory standards.
• Act as lead regulatory reviewer in due diligence for licensing opportunities.
• Supervisory duties and responsibilities may include internal direct reports and external vendor management.

• Review product complaints for completeness of investigation information and assess complaints for MDR or vigilance reporting requirements; submit MDR or vigilance reports as required; maintain MDR/vigilance report files.

Qualifications (Education & Experience)

• Advanced degree in scientific or related field preferred.
• 8-10 years of experience in Regulatory Affairs, including a minimum of 5 years in a team leadership role for IVD companies.
• Demonstrated success creating pre-market and 510K submissions (preference given for previous PMA submissions).
• Hands-on capability in all areas of regulatory submission and regulatory compliance execution.
• Experience writing and processing FDA and international submissions.
• Experience processing MDR & Vigilance reports.
• Experience communicating directly with FDA, Notified Bodies, and OUS Competent Authorities/Ministries of Health.
• In-depth knowledge of FDA regulations, EU regulations, and applicable FDA Guidance and international standards.
• At least 20% travel may be required (to the company, conferences, suppliers, trade shows, regulatory bodies, etc.).

Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing permanent and contract Medical Affairs, Clinical Affairs, Regulatory Affairs, and Medical Communications professionals in life sciences companies in the United States and around the world.